A recent study determined that the risks associated with regular use of low dose aspirin may outweigh the benefits for many patients. The researchers determined that regular aspirin users were 10 percent less likely to have a heart event and 20 percent less likely to have a nonfatal heart attack.  These statistics sound good except that regular aspirin users are also around 30 percent more likely to have serious gastrointestinal (GI) bleeding.  The overall risk of death was the same for both patients who regularly used aspirin and those who did not.

This study looked at nine randomized studies of aspirin use and included more than 100,000 patients.  The study only included patients who had not had a heart attack or stroke and involved giving participants either an aspirin or a placebo to see the benefits of regular doses of aspirin.

These findings have the potential to affect many people since nearly a third of middle-age Americans take a low dose aspirin regularly.  Benefits from aspirin seem to outweigh the risks for people who have a history of heart attacks, but this study calls into question the benefits for patients who are hoping to prevent their first heart attack or stroke.

This issue can be analyzed by building a Cause Map, an intuitive, visual form of root cause analysis.  In this example, the safety goal is the main goal that would be considered because of the higher risk of GI bleeding.  The higher risk of bleeding is caused by the fact that patients are taking aspirin regularly and that GI bleeding is a known side effect of aspirin.  People take aspirin because it has been shown to reduce the likelihood of blood clots.  Reducing blood clots will in turn reduce the risk of heart attacks and stroke since blood clots have the potential to block flow to the brain or heart.

The conclusion that the study draws is that there is no one size fits all solution to the question of whether patients should regularly take low dose aspirin.  The risks and potential benefits need to be determined on a case by case basis by the patient’s physician.  For an individual with a strong family history of heart disease, the benefits may very well outweigh the risk of GI bleeding, but for others the use of aspirin may not be worth the risk.

To view a high level Cause Map of this issue, click on “Download PDF” above.

A study by the Office of the Inspector General (OIG) of the Department of Health and Human Services found that hospital employees are only reporting fourteen percent of all medical errors.  Additionally, the study determined that processes are rarely changed to help prevent similar errors in the future.

The study was conducted by reviewing the medical records of Medicare patients. As a condition of participating in the Medicare program, hospitals are required by federal regulations to track medical errors that harm patients and to implement solutions to protect patients from similar mistakes in the future.  All hospitals involved in the study had a method to collect information on medical errors, but all adverse events were not being efficiently captured by the systems in place.

The study found that out of 293 cases reviewed, only 40 were reported, 28 led to investigations and only five resulted in changes in the hospital’s processes.  Additionally, the inspector general estimated that more than 130,000 Medicare beneficiaries experience at least one adverse event in a hospital in one month so there is a plenty of room for improvement in patient care.

The study found a number of reasons that adverse events and medical errors were not being reported.  Confusion over requirements was one cause of the under reporting because hospital employees did not always recognize that a particular event harmed a patient and was required to be reported.  Also, there were cases where employees assumed someone else would report the incident or they considered the incident to be so common that it didn’t need to be reported.  There was also a tendency to not report things that were considered to be isolated events that were unlikely to recur.

To help combat these causes, the OIG report recommends the development of a standard list of medical errors that should be tracked and reported.  The OIG also recommends that guidance be developed and provided for the accreditors of hospitals since they do not typically investigate adverse event collection methods.  Additionally, some consumer groups are pushing for public reporting of medical errors to help pressure hospitals to improve their policies and practices.

Click on “Download PDF” above to view a high level Cause Map of this event which is an intuitive, visual root cause analysis of this issue.

Concerns over Faulty Implants

January 12, 2012

Thousands of women received faulty breast implants between 2001 and 2010.  These implants contain substandard silicone, not approved for medical use, and are also rupturing at a usually high rate.  It isn’t clear at this time what the long term health risks associated with these implants might be.  The faulty implants were manufactured in France, [...]

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Drug Used to Treat Diabetes May Increase Risk of Heart Disease

January 6, 2012

Since rosiglitazone was approved for use in controlling blood sugar in Type 2 diabetics who did not have success with front line treatments in 1999, studies have shown that this drug (included in trade name drugs Avandia, Avandamet and Avaglim) increases the risk of heart disease in users.  This is of particular concern because most [...]

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Alarm-Related Ventilator Deaths

December 23, 2011

Although The Joint Commission dropped alarm safety as a patient safety goal in 2005 (a year after setting it as a goal), recent reviews by the US Food and Drug Administration and the ECRI Institute have noted concerns with alarm-associated ventilator deaths.  We can look at the issue of alarm-related ventilator deaths in a Cause [...]

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Facial Burns from Surgical Fires

December 14, 2011

At least two patients received burns to the face from surgical fires in early December 2011.  Surgical fires are becoming an increasing risk to patients (and staff) in the operating room.  Although the 550-650 surgical fires a year that are estimated to occur by the ECRI Institute is a small percentage of patients undergoing surgery, [...]

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Surgical Tools Cleaned with Hydraulic Fluid

December 1, 2011

In late 2004, a healthcare system in North Carolina realized that it had been using elevator hydraulic fluid instead of cleaning detergent when cleaning its surgical tools.  Before the problem was realized, the improperly cleaned tools were used on 3,650 patients.  An analysis by infection control, material and toxicology experts determined that the sterilization process [...]

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Bacterial Contamination of Tampons

November 16, 2011

On November 9, 2011, the FDA announced a recall of a certain subset of tampons for contamination with the bacteria Enterobacter sakazakii.  The recall is for certain products delivered to certain stores, mainly in the central U.S. Region.  For a full list of the product  recalls, check the FDA recall site.  The specific source of [...]

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America’s Food Deserts

November 10, 2011

A food desert is a community that lacks adequate access to healthy, nutritious food because they don’t have sufficient stores that sell these items at an affordable price, such as a supermarket. Both isolated rural areas and low income urban neighborhoods are typical locations where a food desert might exist in the United States.  In [...]

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Young Boy Killed by Projectile During MRI

November 2, 2011

It has been over ten years since six year old Michael Colombini died as a result of injuries that occurred during a routine MRI.  He was undergoing a post-surgery MRI after removal of a benign brain tumor when he was hit by a magnetic oxygen tank that was pulled toward the MRI machine at high [...]

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